DISCLAIMER
Page size, page breaks, line spacing, and font size of the printed copy of each of these forms may vary depending on computer, software, and printer combinations.



UAMS
Acknowledgement of Investigator Responsibility for Investigational Devices (MS Word)
HIPAA - Forms
Outpatient Investigational Drug Storage Information Form (PDF)
Tissue Use Agreement Form (MS Word)
UAMS Pharmacy Cost Impact Form (MS Excel)



FEDERAL REGULATIONS
Title 45 Code of Federal Regulations Part 46 (45 CFR 46) Protection of Human Subjects (Revised December 13, 2001)
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 
 
Title 21 Food and Drugs (Regulations applied by the Food and Drug Administration    relevant to human subjects research)         

Part 11 Electronic Records
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr11_01.html

Part 50 Protection of Human Subjects
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr50_01.html

Part 56 Institutional Review Boards
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr56_01.html

Part 312 Investigational New Drug Application
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr312_01.html

Form 1571 (Investigational New Drug Application) and Form 1572 (Statement of Investigator)

Application for FDA Approval to Market a New Drug, Biologic or an Antibiotic Drug for Human Use (21 CFR Part 314)

Part 600 Biologic Products
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr600_01.html

Application Process for FDA Approval of a Biologic License (21 CFR Part 601.2)

Part 812 Investigational Devices
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr812_01.html

Comprehensive Listing of FDA Regulations Relating to Good Clinical Practice and Clinical Trials

Other FDA Forms (Center for Drug Evaluation and Research)

             


GUIDELINES AND REFERENCE MATERIALS
Belmont Report
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

Centers for Medicare and Medicaid Services (formerly known as Health Care Financing Administration) Clinical Trials and Medicare Quick Reference Guide 
http://www.cms.hhs.gov

Declaration of Helsinki
http://www.hhs.gov/ohrp/irb/irb_appendices.htm#j6

The Nuremberg Code
http://www.hhs.gov/ohrp/irb/irb_appendices.htm#j5

Human Subjects Regulations Decision Charts
http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm
Decision charts from the federal Office for Protection from Research Risks (OPRR) regarding the definition of human research, exemption from full board review, waiver of informed consent, and eligibility for expedited review.

Guidelines for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs
http://www.hhs.gov/ohrp/humansubjects/guidance/58fr39406.htm

Fetal Tissue Transplantation –New Statutory Requirement OHRP Guidance
http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc94-02.htm

OHRP IRB Guidebook
http://www.hhs.gov/ohrp/irb/irb_appendices.htm

Federalwide Assurance (FWA) 
http://www.hhs.gov/ohrp/humansubjects/assurance/filasurt.htm

An assurance of compliance, or simply "assurance," is an official document that confirms and defines particular relationships between federal agencies and individual institutions. UAMS and its affiliated institutions have a federal wide assurance that has been approved by the Office for Human Research Protections that formalizes the institution’s commitment to protect human subjects. All institutions "engaged" in federal funded research must have a federal wide assurance approved by OHRP.

Institutional Review Board Guidebook -- From the Office for Human Research Protections
http://www.hhs.gov/ohrp/irb/irb_guidebook.htm/t_top
Provides a basic understanding of the background and purposes of the IRB review system. It should be particularly useful for new IRB members and investigators just beginning their clinical research. The "Guidebook" should not be confused with the IRB Investigator's Handbook for Human Research Studies.

National Bioethics and Safety Commission Report
http://bioethics.georgetown.edu/nbac/human/overvol1.html (Volume 1 (HTML))
http://bioethics.georgetown.edu/nbac/human/overvol2.html (Volume 2 (HTML))
http://bioethics.georgetown.edu/nbac/human/overvol1.pdf (Volume 1 (PDF))

 

OTHER LINKS
HIPAA and HHS Q&A

National Institutes of Health (NIH)

Office for Human Research Protections (OHRP)
(formerly the Office for Protection from Research Risks, or OPRR)

Office of Research Oversight

U. S. Food and Drug Administration (FDA) 

U.S. FDA Good Clinical Practice Web site 

U.S. FDA Medwatch